FDA Coronavirus (COVID-19) Update: June 17th, 2020
June 17, 2020
Silver Spring, MD – The U.S. Food and Drug Administration is taking action in the ongoing response to the COVID-19 Coronavirus pandemic:
The FDA posted a new web page, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents.
Coronavirus
FDA Coronavirus (COVID-19) Update: June 16th, 2020
June 16, 2020
Silver Spring, MD – The U.S. Food and Drug Administration is continuing to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
Today, FDA revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 Coronavirus when a clinical trial was unavailable, or participation in a clinical trial was not feasible.
Coronavirus
Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19
June 14, 2020
Silver Spring, MD – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 Coronavirus diagnostic test utilizing next generation sequence technology.
Coronavirus
FDA Coronavirus (COVID-19) Update: June 13th, 2020
June 13, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) is continuing to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
This week, the FDA issued an Emergency Use Authorization (EUA) for Cue Health Inc.’s Cue COVID-19 Coronavirus Test.
Coronavirus
FDA Coronavirus (COVID-19) Update: June 9th, 2020
June 9, 2020
Silver Spring, MD – The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
On June 6th, 2020, in response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the FDA issued certain Emergency Use Authorizations (EUAs) to revise which respirators the decontamination systems are authorized to decontaminate.
Coronavirus
FDA Coronavirus (COVID-19) Update: June 3rd, 2020
June 3, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continues to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
The agency issued a new FDA Voices, titled Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety, and bylined by Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response.
Coronavirus
Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection
May 31, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) took steps on Friday, May 29th, 2020, to further support the development of COVID-19 Coronavirus tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.
Coronavirus
FDA Provides New Tool to Aid Development, Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection
May 29, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) took a new step to support the agency’s evaluation of diagnostic tests for COVID-19 Coronavirus, by providing a SARS-CoV-2 reference panel.
Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance.
Coronavirus
FDA Coronavirus (COVID-19) Update: May 29th, 2020
May 29, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
The FDA issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS).
Coronavirus
FDA Coronavirus (COVID-19) Update: May 28th, 2020
May 28, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA issued a guidance entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.”
Coronavirus
